olanzapine

Generic: olanzapine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler avpak
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-615
Product ID 50268-615_2b4a7d93-e91a-27be-e063-6294a90a1db0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091415
Listing Expiration 2026-12-31
Marketing Start 2014-04-23

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268615
Hyphenated Format 50268-615

Supplemental Identifiers

RxCUI
312076 314155 351107
UNII
N7U69T4SZR
NUI
N0000175430

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name olanzapine (source: ndc)
Generic Name olanzapine (source: ndc)
Application Number ANDA091415 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX (50268-615-13) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50268-615-11)
source: ndc

Packages (1)

50268-615-13 30 BLISTER PACK in 1 BOX (50268-615-13) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50268-615-11)

Ingredients (1)

olanzapine (5 mg/1)

Linked Drug Pages (1)

OLANZAPINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b4a7d93-e91a-27be-e063-6294a90a1db0", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312076", "314155", "351107"], "spl_set_id": ["98697cfd-5521-f8a9-af17-555031690b08"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (50268-615-13)  / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50268-615-11)", "package_ndc": "50268-615-13", "marketing_start_date": "20140423"}], "brand_name": "OLANZAPINE", "product_id": "50268-615_2b4a7d93-e91a-27be-e063-6294a90a1db0", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "50268-615", "generic_name": "OLANZAPINE", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OLANZAPINE", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA091415", "marketing_category": "ANDA", "marketing_start_date": "20140423", "listing_expiration_date": "20261231"}